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A Phase II Trial of Transplants from HLA-Compatible Donors with T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System for the Treatment of Patients with Hematologic Malignancies and Disorders

Full Title

A Phase II Trial of Transplants from HLA-Compatible Related or Unrelated Donors with CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients with Hematologic Malignancies and Other Lethal Hematologic Disorders

Purpose

An infusion of stem cells from a donor — an allogeneic stem cell transplant — is one way of treating hematologic cancers and disorders. One potential complication of stem cell transplantation is graft-versus-host disease (GvHD). GvHD is caused when cells from the donor view the recipient’s cells as foreign, resulting in symptoms such as rash, diarrhea, nausea, and vomiting, among others.

Removing the T cells (T-cell depletion) from the donor’s stem cell transplant lowers the risk of GvHD. In this study, researchers are assessing an investigational method of T-cell depletion called the CliniMACS system in patients with acute lymphoblastic leukemia (ALL), acute and chronic myelogenous leukemia (AML and CML), non-Hodgkin lymphoma, multiple myeloma, a high-risk form of myelodysplastic syndrome, and other serious diseases of the blood-forming cells.

Patients in this study will receive one of three treatments to treat their cancers and prepare them for a T-cell depleted transplant using CliniMACS. The treatments each involve a combination of chemotherapy drugs, with or without total body irradiation. Researchers are also evaluating how well the blood stem cells grow in the patient’s body, and whether CliniMACS T-cell depleted transplants can prevent GvHD.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have ALL, AML, CML, non-Hodgkin lymphoma, MDS, or multiple myeloma and be candidates for stem cell transplantation.

Patients must have an HLA-compatible donor.

Patients must be under age 75.

For more information and to inquire about eligibility for this study, please contact Dr. Richard O’Reilly at 212-639-5957.